Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— ELECTRODIAB2  

Official title:

ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157480
• Other study ID #: 2014-A00231-46
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary. Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity. Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity. Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning. Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES. To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
• HbA1c : 7 to 10%
• low physical activity (Ricci and Gagnon score below 27)
• Insulin-resistance (at least one criteria out three):
• Waist circumference > 80cm in women and > 94cm in men
• Triglycerides > 150 mg/dl
• HDL-c < 50 mg/dl for women, < 40 mg/dl for men

Exclusion Criteria:

• type 1 diabetes
• pregnancy
• intense usual physical activity
• pace maker
• seizure
• knee or neuromuscular pathology

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Physical Activity
• Type 2 Diabetes

Intervention

Device:
• electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
• electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)

Locations

Country	Name	City	State
France	University Hospital Amiens	Amiens
France	Clinical Research Center University Hospital Caen	Caen
France	University Hospital Lille	Lille
France	General Hospital Roubaix	Roubaix
France	CHU Rouen	Rouen

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Caen	Amiens University Hospital, General Hospital Roubaix, University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fasting plasma glucose		Week 0, 6, 13, 20
Other	fasting plasma insulin		Week 0, 6, 13, 20
Other	FFA (free fatty acid)		Week 0, 6, 13, 20
Other	IL6 (interleukin 6)		Week 0, 6, 13, 20
Other	TNFalpha		Week 0, 6, 13, 20
Other	adiponectin		Week 0, 6, 13, 20
Other	CRPus (C Reactive Protein ultra sensitive)		Week 0, 6, 13, 20
Other	irisin		Week 0, 6, 13, 20
Other	satisfaction questionnaire		Week 0, 6, 13, 20
Other	motivation questionnaire for physical activity		Week 0, 6, 13, 20
Other	cardiometabolic stress test		Week 6, 20
Primary	Mean CGM glucose from a 6-day CGM recording		week 0, 6, 13, 20
Secondary	HbA1c		week 0, 6, 13, 20